| Exclusion Criteria: | 1) Patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to first day of drug dosing
2) Patients who have undergone major surgery within 4 weeks prior to first day of drug dosing
3) Patients who have received another investigational drug within 4 weeks
4) Evidence of leptomeningeal metastasis
5) Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (eg, WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy)
6) Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
7) Patients with risk factors for, or who are receiving medications known to prolong QTc interval and that may be associated with Torsades de Pointes
8) QTc prolongation (defined as a QTc interval >/= 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
9) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, and/or stenting within the past 6 months
10) For patients with history of myocardial infarction, congestive heart failure, abnormal left ventricular ejection fraction (LVEF), and/or prior anthracycline exposure, LVEF < 50%, as assessed by ventriculography (nuclear or heart catheterization) or echocardiogram, when performed within 28 days of first dose of study drug
11) For patients with history of coronary artery disease, cardiac stress test (either exercise or pharmacologic) demonstrates clinically significant abnormalities when performed within 28 days of first dose of study drug
12) Patients with known HIV infection
13) Concurrent systemic hormonal therapy except: stable LHRH agonist therapy for prostate cancer; hormonal therapy (eg, megestrol) for appetite stimulation; nasal, ophthalmic, and topical glucocorticoid preparations when appropriate; stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency; or oral contraceptives
14) Patients who have other medical or psychiatric illness or organ dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent
15) Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing or, if positive, a pregnancy ruled out by ultrasound)
16) Women of childbearing potential or sexually active men unwilling to use adequate contraceptive protection during the course of the study
17) Patients receiving concurrent therapeutic anticoagulation with platelet counts below 150,000/uL |